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GORE? CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

Study category: Brain and Nervous System

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Description

This study will assess the safety and effectiveness of GORE? CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

Details
Age

Adult

Eligibility

Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment. Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver. Patient is able to tolerate antiplatelet therapy

Phase

Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.

Type of Study

Observational

Locations

Harmony Campus
Medical Center of the Rockies

Principal Investigator
Justin Strote

Justin Strote

Study ID

Protocol Number: 19-6030

ClinicalTrials.gov: NCT03821129

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